You Asked: How Worrisome is the Boxed Warning for the New Postpartum Depression Medication?
The package insert advises patients to avoid driving and other potentially hazardous activities after taking zuranolone.
New Oral Drug Zuranolone (Zurzuvae) for Postpartum Depression is Now Available
The FDA approves zuranolone, a new option for the treatment of PPD, a rapidly acting antidepressant with a good safety profile.
Toward a better framework for postmarketing reproductive safety surveillance of medications
Dr. Lee S. Cohen, Director of the Ammon-Pinizzotto Center for Women's Mental Health at Massachusetts General Hospital, recently shared his insights on zuranolone for postpartum depression with Ob.Gyn News on December 14, 2023.
New Oral PPD Treatment Zuranolone Will Soon Hit the Market as Zurzuvae
The FDA approves zuranolone, a new option for the treatment of PPD, a rapidly acting antidepressant with a good safety profile.
FDA Approves Zuranolone for the Treatment of Postpartum Depression
The FDA approves zuranolone, a new option for the treatment of PPD, a rapidly acting antidepressant with a good safety profile.
Zuranolone: Novel, Rapid-Acting Antidepressant Awaits FDA Approval
A New Drug Application for zuranolone awaits FDA approval for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
FDA Accepts New Drug Application for Fezolinetant, A Novel Nonhormonal Treatment for Vasomotor Symptoms
The FDA accepted a New Drug Application for fezolinetant, a novel, nonhormonal selective neurokinin-3 receptor (NK3R) antagonist for the treatment of menopause-related vasomotor symptoms.
Essential Reads: The Pregnancy and Lactation Labeling Rule (PLLR)
The PLLR helps to put the potential effects of the drug into perspective with the goal of providing a more individualized risk-benefit analysis.
Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application for Zuranolone to the FDA in 2022
The FDA will review zuranolone for the treatment of depression in the first half of 2022.
How to Find Information on the Reproductive Safety of Medications
Last week, I met with a woman who was planning pregnancy. She had a long history of generalized anxiety disorder and panic disorder and had done very well over the past 10 years on [...]